DIAGNOSTIC KIT

The kit is fully validated and registered by the State Institute for Drug Control (SÚKL) under registration number 00912050 (issued by SIDC-CZ). Instructions and a valid declaration of conformity can be downloaded from the appendix of this registration. It is a completely Czech product without dependence on foreign suppliers.

The kit is intended for diagnosis of the presence of SARS-CoV-2 virus in isolated viral RNA samples – for 45 samples. The diagnostic kit involves the detection of SARS-CoV2 virus and the detection of an internal control (IC) to check the correct collection and processing of the sample.

The functional evaluation was successfully performed by the Institute of Molecular and Translational Medicine in Olomouc. Comparison of the kit with the reference RT-PCR assay determined the sensitivity of the assay to be 93% and specificity to 99%. The kit passed all tested parameters and was recommended for use.

Test sensitivity:

• Equivalent sensitivity with qPCR up to Ct 36-38

• Corresponds to 10 copies of virus per ul sample

Kit contents:

• A bag containing a 96-hole PCR plate and a plate of colored caps in a light-tight package. Should be stored at room temperature, caps in the original light-tight package or in the dark.

• Reagent box for 45 tests

IC = internal control; PC = positive control

Material required – not supplied with the kit:

• Automatic and multichannel pipettes

• Appropriate reservoir for the reaction mixture

• Pipette tips with RNAse and DNAse free aerosol filters

• Plate incubation device at 63 °C